Danish biotech company, Acesion Pharma, has started the Phase I clinical study for its lead compound AP30663, which demonstrated a good safety profile and efficacy in converting atrial fibrillation (AF) to normal sinus rhythm in the preclinical development programme.
atrial fibrillation
The Phase I study is a randomised, double-blind, placebo-controlled single ascending dose study to assess the safety and tolerability of AP30663 in nearly 50 healthy subjects. It is expected to be completed in June 2018 with the data anticipated by the end of August 2018. It is being conducted at the Centre for Human Drug Research (CHDR) in the Netherlands.
AF is a common cardiac arrhythmia affecting 30 million people worldwide. Existing drug therapies to treat AF have encountered safety issues as a result of their effects on the ventricles. Acesion’s approach is based on inhibition of SK channels — ion channels present in the atria that play a role in regulating the cardiac rhythm. Through blocking these channels with a functionally atrial selective drug helps to avoid the deleterious effects on the ventricles, thereby offers a novel and promising approach for an effective AF treatment with an anticipated higher safety and tolerability profile.
“I am delighted to announce the first in-man study for our lead candidate is progressing as planned,” revealed Frans Wuite, CEO of Acesion Pharma. “Acesion’s mission is to develop first-in-class treatments that offer unique efficacy and safety profile for atrial fibrillation patients. There is a large unmet medical need for these patients where current treatments have safety, tolerability and efficacy limitations.”